Salix rifaximin NDA plans OK despite new guidance
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Salix has reached agreement on a regulatory pathway for a non-constipation irritable bowel syndrome indication for rifaximin, following a Dec. 8 pre-NDA meeting. The company confirmed that the prior agreements made with the Gastrointestinal Drugs review division, including the protocol-specified primary and key secondary endpoints used in the TARGET 1 and 2 trials as the basis for approval in non-C IBS - an important step since the Gastroenterology Division and the Study Endpoint and Labeling Development Team are at work on a new guidance for endpoints in IBS clinical trials. "The Phase III trials were designed, in consultation with the Division, to investigate the utility of rifaximin in non-C IBS by assessing adequate relief of IBS-related bloating and other endpoints such as abdominal pain and stool consistency," the firm said. Rifaximin is already approved in the U.S. for traveler's diarrhea, as Xifaxan. Salix is targeting an NDA submission for the new indication for the first half of 2010. An NDA is already pending for an indication for maintaining remission of hepatic encephalopathy, and the drug is being studied for use in Clostridium dificile infections
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